METHYLATION SPECIFIC PCR FOR CANCER DIAGNOSIS/PROGNOSIS

APPLICANT?S DESCRIPTION: UroCor, Inc., seeks to develop and optimize the technology of gene specific hypermethylation detection and determine the feasibiity of delivering diagnostic and/or prognostic methylation assays to the marketplace. The recognition that aberrant gene methylation plays an important role in carcinogenesis has increased in recent years. The number of genes known to undergo hypermethylation and the role of hypermethylation gene silencing in cancer has also increased. The recent development of rapid and sensitive technology for the detection of DNA methylation have made the possibility of clinically informative assays attractive. The Specific Aims for this Phase I proposal are: Specific Aim I: Development of solution-phase Methylation Specific PCR to amplify and detect methylated target genes in isolated genomic DNA. Specific Aim II: Development of Methylation Specific PCR-in situ hybridization for use on prostate needle core biopsy sections. Specific Aim III: Comparison of solution-phase Methylation Specific PCR to Methylation Specific PCR-in situ hybridization using prostate needle core biopsies. This research will also allow the creation of defined assay protocols for use in the potential Phase II SBIR of this project, the determination of clinical utility of these assays with large, prospective, multicenter IRB-approved clinical trials. PROPOSED COMMERCIAL APPLICATION: This proposal will determine the feasibility of using methylation detection assays in the clinical laboratory. More than a quarter million Americans are expected to be diagnosed with prostate, bladder or kidney cancer. If the average unit re-imbursement is approximately $100, the above population represents $25 million in annual revenue, assuming only one test per patient, and no tests to monitor the course of the disease. UroCor, Inc. has the sales and marketing ability to deliver such a test to the urologic community.